FDA Adverse Event
Malfunction
Summary report: N
OCCLUDER¿
MDR report key: 6981150
·
Received October 26, 2017
Report
- Report Number
- 3005099803-2017-03288
- Event Type
- Malfunction
- Date Received
- October 26, 2017
- Report Date
- October 1, 2017
- Product Code
- KOD
- PMA / PMN Number
- K841941
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
FOR THIS EVENT RELATED TO EXEMPTION NUMBER E2012014, THE DEVICE WAS DISPOSED.
Description of Event or Problem · 1
THIS MANUFACTURER REPORT IS BEING SENT AS A REQUIREMENT UNDER SUMMARY REPORTING EXEMPTION APPROVAL NUMBER - E2012014 FOR PRODUCT CODE KOD. THIS REPORT SUMMARIZES 1 EVENT REPORTED TO BOSTON SCIENTIFIC FOR OCCLUDER BALLOON CATHETER BALLOON BURST. THE PATIENTS SEX AND AGE ARE BOTH UNKNOWN ALONG WITH ALL OTHER DEMOGRAPHIC INFORMATION .
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 761213 | OCCLUDER¿ | CATHETER, UROLOGICAL | KOD | M0062201090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |